WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K251938

510(k) cleared

GEN5 and GEN5+ Dental Implant System

Paragon Implant Mfg., LLC · Oct 30, 2025 · K251938

FDA cleared the GEN5 and GEN5+ Dental Implant System from Paragon Implant Mfg., LLC on Oct 30, 2025 under K251938, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 24, 2025. The decision came 128 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Paragon Implant Mfg., LLC has 3 other decisions in the tracker over the last 12 months: K250476 (NizPlant Dental Implant System), K252145 (GEN5 and GEN5+ 3.3mmD Dental Implants), K251756 (Sterilization Trays).

Questions & Answers

What did FDA clear under K251938?

K251938 is the FDA 510(k) for GEN5 and GEN5+ Dental Implant System, submitted by Paragon Implant Mfg., LLC. FDA's decision date was Oct 30, 2025, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the GEN5 and GEN5+ Dental Implant System?

Paragon Implant Mfg., LLC, based in Calabasas, CA, is the applicant of record for K251938.

How long did the K251938 review take?

FDA received the submission on Jun 24, 2025 and issued its decision on Oct 30, 2025, 128 days later.

← All decisions in October 2025

Sources